FDA WARNING_LETTER - Premiumecigsmoking.com

The FDA Center for Tobacco Products issued a Warning Letter to Ms. Osborne regarding the website http://www.premiumecigsmoking.com, which sells e-liquids to U.S. customers. The FDA determined that "Clouds of Hope E Liquid Strength (mint, chocolate, cookie)" e-liquid is a tobacco product under section 201(rr) of the FD&C Act and is misbranded under section 903(a)(7)(B) of the FD&C Act.

The violation stems from the sale of this e-liquid to a person younger than 18 years of age, which violates 21 C.F.R. § 1140.14(b). This regulation prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a minor successfully purchased the specified e-liquid from the website.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, is required within 15 working days.